Telehealth and off-label prescribing requires doctors to ‘demonstrate even greater rigour’, AHPRA says.
A patient wanting a medicine does not constitute a clinically justified reason for a doctor to prescribe that medicine – that’s the take-home message from new AHPRA guidance on prescribing off-label, unapproved, or compounded medicines.
Released today, the guidance asked prescribers to ensure they had the “necessary knowledge, skills and training” to provide safe care.
Specific examples of poor practice in this space, according to AHPRA, would include prescribing without a legitimate indication, a consultation taking a few minutes or less, not checking the real-time prescription monitoring systems before prescribing, and not adequately declaring a conflict of interest.
The very first point the guidance set out was to establish therapeutic need.
“Patient demand alone is not a valid reason to prescribe a medicine,” it read.
“Off-label, unapproved, or compounded medicines should only be prescribed when there is sufficient evidence, a clear clinical indication or when other treatments have not worked or are inappropriate for the patient.”
The release of the guidance coincided with new reports about harms related to unapproved peptide products, which some patients might be seeking for weight-loss purposes.
Earlier this week, the TGA confirmed that one patient had torn their oesophagus as a result of taking a counterfeit peptide medicine.
“Peptides are like other drugs: A patient may want peptides, but that doesn’t mean they need peptides,” she said.
“It doesn’t mean that peptides are clinically justified. Practitioners need to use their judgement, skills and experience to do what is best for their patient.”
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AHPRA’s second guidance point covered informed patient consent.
To give valid informed consent, the regulator said, the patient had to understand that their prescribed medicine was not approved for the intended use and that it had not been assessed by the TGA for safety, efficacy, and quality.
“Prescribers considering unapproved medicines should ensure they understand the relevant legal pathways and obligations under the Therapeutic Goods Act 1989, as well as their professional responsibilities to patients,” TGA head Professor Anthony Lawler said.
“These guidelines will help practitioners make informed prescribing decisions and support safe patient care.”
The third point was documentation – patient-specific risk versus benefit analysis, clinical reasoning, records of informed consent, recognition of conflict of interest, and facilitating continuity of care.
AHPRA’s guidance ends with a “word of caution”, warning that it is working with other regulators to understand prescribing patterns.
“We may investigate the practice of practitioners with high rates of prescribing or compounding of any scheduled medicine, even if we have not received a complaint,” it said.
The regulator’s accompanying press release also mentioned that its “intelligence-gathering and investigative methods continue to evolve to meet emerging risks”.
The regulator would also be releasing new guidance on managing conflicts of interest in prescribing, which it said was a direct follow-on from 2025 compliance action on medicinal cannabis and non-surgical cosmetic procedures.
